IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
Central Nervous System Agents
idebenone SNT MC17 N6D, N7X, M5X Filed
bis-aryl-sulphanyl amine LU AA21004 N6A9 III
venlafaxine WY 45030 N6A5, N5C, N7X III
bis-aryl-sulphanyl amine LU AA24530 N6A9 II
diabetic neuropathy therapy TAK 428 N7X II
PHN therapy TAK 583 N7X II
neuroregeneration enhancer TAK 065 N4A, N7D9 I
IDEBENONE is a com pound orig i nally de vel oped by Santhera (Swit zer land). It was orig i nally de vel oped
as a brain me tab o lism-im prov ing drug and was launched in a num ber of coun tries by var i ous li cens ees,
no ta bly Abbott (USA) and Takeda. It was launched as Avan in Ja pan in 1987 by Takeda, but was delisted
from re im burse ment in Ja pan in 1998, to gether with a num ber of sim i lar prod ucts, due to efficacy
concerns.
Santhera has now be gun tri als in new in di ca tions. In 2005, Santhera com menced a Eu ro pean phase III
trial of idebenone in Friedreich’s Ataxia (FRDA) pa tients. In Au gust 2007, the EMEA ac cepted the fil ing of
an MAA for idebenone for the treat ment of Friedreich’s Ataxia; a reg u la tory fil ing in this in di ca tion was ac -
cepted by Swissmedic in Oc to ber 2007 and Health Can ada in No vem ber 2007. Idebenone has been
granted or phan drug des ig na tion in the EU and could be come the first ap proved prod uct for the treat -
ment of FRDA. A US phase III trial in pa tients with Friedreich’s Ataxia was ini ti ated in the USA in Sep tem -
ber 2007. In No vem ber 2008 Santhera re ported that the EMEA has con firmed its orig i nal neg a tive
opin ion (is sued in July 2008) on the EU MAA for idebenone (SOVRIMA;SNT MC17) in Friedreich’s ataxia.
The CHMP of the EMEA an nounced that it pre ferred to wait for ad di tional re sults from at least one of two
piv otal tri als. Santhera in tends to file for marketing authorization in the USA and the EU in 2009.
Santhera is also con duct ing a phase II trial to eval u ate the agent as a ther apy for Du chenne Mus cu lar
Dystropy. Santhera is de vel op ing idebenone as a po ten tial treat ment for Leber’s he red i tary op tic neu rop -
a thy; reg u la tory ap prov als for phase IIa tri als in the UK and Ger many have been granted.
Li cens ing: In 2005, Takeda ob tained mar ket ing rights in the EU and Swit zer land to idebenone for the
treat ment of Friedreich’s ataxia; Santhera will con duct all clin i cal tri als of idebenone. In Au gust 2007
Santhera granted Takeda mar ket ing rights in the EU and Swit zer land to idebenone for the treat ment of
DMD.
Pat ents: Takeda filed a pri or ity pat ent ap pli ca tion in Ja pan in 1974. All com po si tion of mat ter pat ents for
idebenone have ex pired and Santhera holds a method of use pat ent for idebenone for the treat ment of
Friedreich’s ataxia, in the USA and Canada.
LU AA21004, a bis-aryl-sulphanyl amine SRI an ti de pres sant com pound en tered phase III de vel op ment
for the treat ment of ma jor de pres sive dis or der (MDD) in De cem ber 2007. A phase I trial of Lu AA21004
was re ported to be un der way in Ja pan in 2009. Bis-aryl-sulphanyl amines is a new chem i cal class of novel
psychotropics, and ac cord ing to Lundbeck, the in vi tro phar ma co log i cal pro file LU AA21004 shows that it
com bines po tent ef fect on sev eral se ro to nin re cep tors and se ro to nin trans porter pro teins. The com pound
acts as a se ro to nin mod u la tor and stimulator and mod u lates rel e vant parts of the neurochemical ar chi -
tec ture in the brain in a ben e fi cial way. Com pared with cur rently ap proved an ti de pres sants, pre clin i cal
mod els have dem on strated that the com pounds have the po ten tial to ad dress im por tant un met needs for
pa tients in terms of both fast on set of ef fect and in creased ef fi cacy. This prod uct is one of Takeda’s pri or -
ity prod ucts in the CNS field and the advancement to phase III represents a significant achievement for
Takeda’s CNS pipeline.
Li cens ing: In Sep tem ber 2007, Takeda an nounced a stra te gic al li ance with Lundbeck (Den mark) for the
ex clu sive co-de vel op ment and co-com mer cial iza tion in the USA and Ja pan of sev eral com pounds in
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